3.0 Responsibility

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Distinguish the results in three categories as follows.1. Normal level2. Alert level3. Action level5.2 No action is required for results observed in normal level and below alert level category.5.3 Consider the results, observed above normal level and below action level as an alert level category.5.3.1 On the alert trend of results inform to Q.A and Production department.5.4 Initiate the preventive action for any action level or critical results.5.4.1 In action level results, a deviation report must be submitted to Production, Q.A and Quality control (Microbiological testing lab) and to be involved in deciding the action to be taken.5.5 Evaluate the results and decide that up to what extent and how much identification is relevant based on comments from production. Identify all microorganisms found in the critical areas up to a level for determining the origin of the same.5.6 Send the trend analysis report to QA dept. for evaluation of trend.5.7 Frequency of trend analysisLocation FrequencySurface samples and air samples in class 100 and 10,000 area Once in weekSurface samples and air samples in class 100,000 area Once in quarter Fingerprint and gown personnel working in Green Area Once in quarter Settling plate in solid dosage area Once in quarterSettling plate in Raw material dispensing and sampling booth Once in quarterSurface sample and air samples in 100 and 10,000 area Once in a monthIn sterility room and inoculum room in microbiology laboratory Once in a monthSettling plate in sterility testing and inoculation room microbiology lab. Twice in a monthFingerprint and gown of person working in sterility Once in quarter Inoculation room and nonviable particle count in microbiology lab Once in quarter